Sensitivity and specificity of Real-time RT-PCR kits for detection SARS-CoV-2 Omicron (B.1.1.529) variant

Abstract

Background: Coronavirus disease 2019 (COVID-19) is a pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which has quickly spread around the world since early December 2019. The real-time RT-PCR technique is a gold standard method for detecting SARS-CoV-2, but most laboratories do not differentiate and report variants of SARS-CoV2. Objective: This study aimed to evaluate the sensitivity, specificity, and accuracy of Bioperfectus Technologies SARS-CoV-2 Variant Omicron (B.1.1.529) Real Time PCR Kit (RUO). Method: Nasopharyngeal and throat swabs were collected at Rajavithi hospital from December 2021 to March 2022. All 100 samples (Omicron 50 and Non omicron 50) were evaluated by using Bioperfectus Technologies SARS-CoV-2 Variant Omicron (B.1.1.529) Real Time PCR Kit. Result: For Omicron samples, the result showed 100% of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy, without cross reactivity. Non Omicron samples consisted of 8 Delta variant samples and 42 SARS-CoV-2 Negative samples. Conclusion: The result of this study demonstrated that commercial Real-time PCR kit could be used to detected Omicron (B.1.1.529) variant in Biomolecular Laboratory, Rajavithi hospital. But it might be inapplicable for early diagnosis of SARS-CoV-2. Moreover, the development of the novel commercial kit for detecting VOC other than Omicron (B.1.1.529) would be an essential information for preventing of COVID-19 pandemic in the future.